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Multicomponent intervention to prevent mobility disability in frail older adults : randomised controlled trial (SPRINTT project)

Multicomponent intervention to prevent mobility disability in frail older adults : randomised controlled trial (SPRINTT project)


Title: Multicomponent intervention to prevent mobility disability in frail older adults : randomised controlled trial (SPRINTT project)
Author: SPRINTT consortium
Date: 2022-05-11
Language: English
Scope: e068788
University/Institute: Landspitali - The National University Hospital of Iceland
Department: Faculty of Medicine
Geriatric and Rehabilitation Services
Series: BMJ (Clinical research ed.); 377()
ISSN: 0959-8146
DOI: https://doi.org/10.1136/bmj-2021-068788
Subject: Öldrunarlæknisfræði; Aged; Frail Elderly; Independent Living; Sarcopenia* / prevention & control; Sarcopenia/prevention & control; Humans; Child, Preschool; Female; Frailty; Male; Hand Strength; Medicine (all)
URI: https://hdl.handle.net/20.500.11815/3458

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Citation:

SPRINTT consortium 2022 , ' Multicomponent intervention to prevent mobility disability in frail older adults : randomised controlled trial (SPRINTT project) ' , BMJ (Clinical research ed.) , vol. 377 , e068788 , pp. e068788 . https://doi.org/10.1136/bmj-2021-068788

Abstract:

OBJECTIVE: To determine whether a multicomponent intervention based on physical activity with technological support and nutritional counselling prevents mobility disability in older adults with physical frailty and sarcopenia. DESIGN: Evaluator blinded, randomised controlled trial. SETTING: 16 clinical sites across 11 European countries, January 2016 to 31 October 2019. PARTICIPANTS: 1519 community dwelling men and women aged 70 years or older with physical frailty and sarcopenia, operationalised as the co-occurrence of low functional status, defined as a short physical performance battery (SPPB) score of 3 to 9, low appendicular lean mass, and ability to independently walk 400 m. 760 participants were randomised to a multicomponent intervention and 759 received education on healthy ageing (controls). INTERVENTIONS: The multicomponent intervention comprised moderate intensity physical activity twice weekly at a centre and up to four times weekly at home. Actimetry data were used to tailor the intervention. Participants also received personalised nutritional counselling. Control participants received education on healthy ageing once a month. Interventions and follow-up lasted for up to 36 months. MAIN OUTCOME MEASURES: The primary outcome was mobility disability (inability to independently walk 400 m in <15 minutes). Persistent mobility disability (inability to walk 400 m on two consecutive occasions) and changes from baseline to 24 and 36 months in physical performance, muscle strength, and appendicular lean mass were analysed as pre-planned secondary outcomes. Primary comparisons were conducted in participants with baseline SPPB scores of 3-7 (n=1205). Those with SPPB scores of 8 or 9 (n=314) were analysed separately for exploratory purposes. RESULTS: Mean age of the 1519 participants (1088 women) was 78.9 (standard deviation 5.8) years. The average follow-up was 26.4 (SD 9.5) months. Among participants with SPPB scores of 3-7, mobility disability occurred in 283/605 (46.8%) assigned to the multicomponent intervention and 316/600 (52.7%) controls (hazard ratio 0.78, 95% confidence interval 0.67 to 0.92; P=0.005). Persistent mobility disability occurred in 127/605 (21.0%) participants assigned to the multicomponent intervention and 150/600 (25.0%) controls (0.79, 0.62 to 1.01; P=0.06). The between group difference in SPPB score was 0.8 points (95% confidence interval 0.5 to 1.1 points; P<0.001) and 1.0 point (95% confidence interval 0.5 to 1.6 points; P<0.001) in favour of the multicomponent intervention at 24 and 36 months, respectively. The decline in handgrip strength at 24 months was smaller in women assigned to the multicomponent intervention than to control (0.9 kg, 95% confidence interval 0.1 to 1.6 kg; P=0.028). Women in the multicomponent intervention arm lost 0.24 kg and 0.49 kg less appendicular lean mass than controls at 24 months (95% confidence interval 0.10 to 0.39 kg; P<0.001) and 36 months (0.26 to 0.73 kg; P<0.001), respectively. Serious adverse events occurred in 237/605 (39.2%) participants assigned to the multicomponent intervention and 216/600 (36.0%) controls (risk ratio 1.09, 95% confidence interval 0.94 to 1.26). In participants with SPPB scores of 8 or 9, mobility disability occurred in 46/155 (29.7%) in the multicomponent intervention and 38/159 (23.9%) controls (hazard ratio 1.25, 95% confidence interval 0.79 to 1.95; P=0.34). CONCLUSIONS: A multicomponent intervention was associated with a reduction in the incidence of mobility disability in older adults with physical frailty and sarcopenia and SPPB scores of 3-7. Physical frailty and sarcopenia may be targeted to preserve mobility in vulnerable older people. TRIAL REGISTRATION: ClinicalTrials.gov NCT02582138.

Description:

Funding Information: 17Cognitive and Motor Centre, Medicine and Geriatric Rehabilitation Department of Parma, University Hospital of Parma, Parma, Italy 18Translational Medicine, Novartis Institutes for Biomedical Research, Cambridge, MA, USA 19Servicio de Geriatría, Hospital Universitario de Getafe, Getafe, Spain 20Department of Internal Medicine, Medizinische Universität Graz, Graz, Austria 21Silesian Hospital in Opava, Opava, Czech Republic 22Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma, Biberach an der Riss, Germany 23Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Universiteit Maastricht, Maastricht, Netherlands 24Institute for Biomedicine of Aging, Friedrich-Alexander-Universität Erlangen-Nürnberg, Nurnberg, Germany 25Diabetes Frail, Droitwich Spa, UK 26Department of Internal Medicine and Gerontology, Uniwersytet Jagiellonski Collegium Medicum, Faculty of Medicine, Krakow, Poland 27University of Helsinki and Helsinki University Hospital, Helsinki, Finland 28University of Oulu, Centre for Life Course Health Research, Oulo, Finland 29Pôle Gérontologie Clinique, Centre Hospitalier Universitaire de Limoges, Limoges, France 30First Faculty of Medicine, Univerzita Karlova v Praze, Prague, Czech Republic 31Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France 32Department of Cardiology and Pneumology, University of Goettingen Medical Centre, Goettingen, Germany 33Institute on Aging, University of Florida, Gainesville, FL, USA 34Translational Medicine, Novartis Institutes for Biomedical Research, Basel, Switzerland SPRINTT consortium partners are listed in the supplementary appendix. We thank Stefania Maggi (Università degli Studi di Padova, Padua, Italy), Federico Marini (Sapienza Università di Roma, Rome, Italy), and Renuka Visvanathan (University of Adelaide, Adelaide, Australia) for their services as members of the data safety and monitoring board; Nicolás Martínez-Velilla (Universidad Pública de Navarra, Pamplona, Spain), Mirko Petrovic (Universiteit Gent, Gent, Belgium), and Renzo Rozzini (Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy) for their services as members of the adjudication committee; Luigi Ferrucci (National Institute on Ageing, Bethesda, MD) for his intellectual contribution to the development and deployment of the study; and Roger Fielding and the research staff of the Institute on Ageing at the University of Florida (Gainesville, FL) for their assistance in the standardisation of trial procedures. Contributors: RB and FL contributed equally to this article as co-primary authors. AC, EM, FrL, MC, MDB, MP, RoB, RC, RRM, SDA, and SDS conceived and designed the study. EM, MC, MT, RaB, and RC wrote the protocol. AJC-J, AJS, AMWJS, AS, AT, BV, CCS, ET, FaL, FrL, IR, LR-M, MM, PVJ, RR-W, and TS coordinated participant recruitment. MT and RC supervised the interventions. HG and RaB designed the statistical analysis plan. AC, AJC-J, EM, and MDB critically reviewed the statistical analysis plan. HG and RaB performed the statistical analysis. TF replicated the statistical analysis. EM and RC drafted the manuscript. AC, CGA, HG, JS, MC, MDB, MK, MP, MT, RR, RoB, SDA, and SvH critically reviewed the manuscript for important intellectual content. RoB and SDS obtained funding. LM and PB provided administrative and technical support. All authors read and approved the final manuscript. EM, FrL, RC, RR, and RoB act as guarantors, accept full responsibility for the work, had access to the data, and controlled the decision to publish. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Funding: This work was funded by a grant from the Innovative Medicines Initiative Joint Undertaking (IMI−JU 115621), which included in-kind support by member companies of the European Federation of Pharmaceutical Industries and Associations (Sanofi-Aventis, Novartis, GlaxoSmithKline, Servier, Astellas Pharma, and Boehringer Ingelheim). The funder had no role in the study design, data collection, data analysis, data interpretation, writing of the report, or decision to submit the article for publication. Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: The present work was funded by a grant from the Innovative Medicines Initiative Joint Undertaking. AC, AJC-J, AJS, AMWJS, AS, AT, BV, CCS, EM, ET, FaL, FrL, IR, LM, LR-M, MC, MDB, MM, MT, PVJ, RB, RC, RR-W, SDA, SvH, and TS received in-kind support from the European Federation of Pharmaceutical Industries and Associations as part of the Innovative Medicines Initiative Joint Undertaking for the submitted work; CGA is a full time employee of Servier; HG, PB, and RaB are full time employees of Sanofi-Aventis; JS is a full time employee of Boehringer Ingelheim Pharma; MK is a full time employee of Astellas Pharma; RR and RRM are full time employees of Novartis; AJJ-C received grant support from Abbott Nutrition, Fresenius Kabi, and Nutricia outside of the submitted work, and personal fees from Abbott Nutrition, Fresenius Kabi, Nestlè, Nutricia, Pfizer, and Sanofi-Aventis outside of the submitted work; EM received personal fees from Abbott, Nestlè, Nutricia, and Thermofisher outside the submitted work; MC received personal fees from Nestlè outside the submitted work; RC received personal fees from Abbot and Nutricia outside the submitted work; SDA received grant support from Abbott and Vifor Pharma outside of the submitted work, and personal fees from Abbott, Bayer, Boehringer Ingelheim, Cardiac Dimension, Cordio, Impulse Dynamics, Novartis, Occlutech, Servier, and Vifor Pharma outside of the submitted work; SDS has a pending US patent; SvH received grant support from Amgen, Boehringer Ingelheim, and ZS Pharma outside of the submitted work and personal fees from AstraZeneca, Bayer, BRAHMS, Chugai, Grünenthal, Helsinn, Hexal, Merck Sharp and Dohme, Novartis, Pharmacosmos, Respicardia, Roche, Servier, and Sorin outside the submitted work; TF received personal fees from Bayer, BiosenseWebster, CSL Behring, Coherex Medical, Fresenius Kabi, Galapagos, Janssen, LivaNova, Minoryx, Novartis, Parexel, Penumbra, Roche, and Vifor Pharma outside the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. Ethical approval: The study protocol was approved by the ethics committee of the Università Cattolica del Sacro Cuore, Rome, Italy (protocol No 15611/15), and was subsequently ratified by the ethics committees of all participating institutions. Publisher Copyright: © 2022 BMJ Publishing Group. All rights reserved. © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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